Compliance with USP <800> – the United States Pharmacopeia (USP) standards for the safe handling of hazardous drugs – is no longer optional for many pharmacies, as it is required by law in many states, as well as by certain payors and accreditors. It is a critical component of protecting staff, patients, and your practice. With state Boards of Pharmacy increasingly including USP <800> in their inspections and PBMs scrutinizing hazardous drug handling protocols, pharmacies must ensure they meet applicable USP <800> requirements adopted by their state and their payor contracts.
As a law firm with extensive experience in pharmacy compliance, Frier Levitt understands the evolving regulatory landscape and the risks pharmacies face. Below are key takeaways every pharmacy should know about USP <800> and how to prepare for the new era of enforcement.
Understanding the Scope and Intent of USP <800>
USP <800> was developed by the United States Pharmacopeia to minimize the risk of exposure to hazardous drugs (HDs) in healthcare settings. The standard applies to all healthcare personnel who handle HDs, including pharmacists, pharmacy technicians, nurses, and even custodial staff. Its intent is to protect both employees and patients from the harmful effects of these substances, which can include carcinogenicity, reproductive toxicity, and organ damage. “Handling” includes receiving, unpacking, storing, compounding, dispensing, transporting, administering, cleaning, spill control, and disposal. Importantly, the requirement to abide by USP <800> is not limited to compounding pharmacies, USP <800> creates safety standards incumbent on all healthcare providers maintaining HDs. Pharmacies should maintain an HD list based on the current the National Institute for Occupational Safety and Health (NIOSH) hazardous drug list.
Core Compliance Requirements: Policies, Training, and Engineering Controls
USP <800> compliance is multi-faceted. Pharmacies must:
- Conduct internal audits to identify and address gaps in compliance.
- Develop and implement written policies and procedures covering all aspects of HD handling, from receipt to disposal.
- Provide comprehensive training for all staff who may handle HDs. The training should address compounding and controlling spills.
- Install and maintain engineering controls such as negative pressure rooms, appropriate ventilation, and containment primary engineering controls (C-PECs) for compounding.
- Ensure proper use of personal protective equipment (PPE) and maintain rigorous cleaning protocols.
- Maintain a spill kit and store HDs appropriately.
- Designate a qualified person responsible for USP <800> compliance and documentation.
- Maintain a medical surveillance program for personnel handling HD consistent with USP <800> recommendations.
Risks of Non-Compliance: Regulatory and Patient Safety
Non-compliance with USP <800> exposes pharmacies to significant regulatory risks:
- Regulatory Penalties: Boards of Pharmacy in many states cite USP <800> during routine inspections. Violations can result in fines, license suspension, or even revocation. For example, California Board of Pharmacy initiated disciplinary proceedings against a San Diego-based pharmacy for a compounding-related death. Investigations revealed that the pharmacy failed to comply with compounding standards, including USP <800>. The pharmacy was ultimately ordered to surrender their sterile compounding permit and lost all rights and privileges to perform sterile compounding.
- PBM Contract Jeopardy: Pharmacy Benefit Managers (PBMs) are increasingly auditing hazardous drug handling protocols. Non-compliance with industry standards and state Board of Pharmacy regulations can lead to exclusion from networks.
- Patient and Staff Harm: Failure to follow USP <800> can be used by the Occupational Safety and Health Administration (OSHA) as evidence that an employer failed to provide a workplace free from recognized hazards likely to cause death or physical harm. Potential consequences include citations, penalties, and increased liability exposure for employers who do not implement appropriate hazardous drug safety measures.
- Operational Disruption: Non-compliance can often result in temporary service disruptions or costly facility upgrades to comply with remediation plans.
How Frier Levitt Can Help
Our attorneys can assist pharmacies in navigating the complexities of USP <800> compliance by reviewing and developing policies and procedures to train pharmacy staff, preparing the pharmacy for audits and inspections, and challenging adverse determinations by state Boards of Pharmacy and PBMs.
Don’t wait for an inspection or audit to discover compliance gaps. Contact us today to ensure your pharmacy is fully aligned with USP <800> and protected from regulatory and legal risk.
Associate
Senior Counsel
